The Population Pharmacokinetics of High-Dose Methotrexate in Infants with Acute Lymphoblastic Leukemia Highlight the Need for Bedside Individualized Dose Adjustment: ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-02-27

AUTHORS

Ryan J. Beechinor, Patrick A. Thompson, Michael F. Hwang, Ryan C. Vargo, Lisa R. Bomgaars, Jacqueline G. Gerhart, ZoAnn E. Dreyer, Daniel Gonzalez

ABSTRACT

BACKGROUND: Infants with acute lymphoblastic leukemia (ALL) treated with high-dose methotrexate may have reduced methotrexate clearance (CL) due to renal immaturity, which may predispose them to toxicity. OBJECTIVE: The aim of this study was to develop a population pharmacokinetic (PK) model of methotrexate in infants with ALL. METHODS: A total of 672 methotrexate plasma concentrations were obtained from 71 infants enrolled in the Children's Oncology Group (COG) Clinical Trial P9407. Infants received methotrexate 4 g/m2 intravenously for four cycles during weeks 4-12 of intensification. A population PK analysis was performed using NONMEM® version 7.4. The final model was evaluated using a non-parametric bootstrap and a visual predictive check. Simulations were performed to evaluate methotrexate dose and the utility of a bedside algorithm for dose individualization. RESULTS: Methotrexate was best characterized by a two-compartment model with allometric scaling. Weight was the only covariate included in the final model. The coefficient of variation for interoccasion variability (IOV) on CL was relatively high at 25.4%, compared with the interindividual variability for CL and central volume of distribution (10.7% and 13.2%, respectively). Simulations identified that 21.1% of simulated infants benefitted from bedside dose adjustment, and adjustment of methotrexate doses during infusions can avoid supratherapeutic concentrations. CONCLUSION: Infants treated with high-dose methotrexate demonstrated a relatively high degree of IOV in methotrexate CL. The magnitude of IOV in the CL of methotrexate suggests that use of a bedside algorithm may avoid supratherapeutic methotrexate concentrations resulting from high IOV in methotrexate CL. More... »

PAGES

1-12

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40262-018-00734-0

DOI

http://dx.doi.org/10.1007/s40262-018-00734-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112400553

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30810947


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